Ovary; Anomaly
Conditions
Brief summary
This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.
Detailed description
In primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. Patients will be identified by the GYN physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure. In exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed before making decision to undergo prophylactic oophorectomy. Patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.
Interventions
DEVICEPhotoacoustic imaging
-Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample
DEVICEUltrasound
-The ultrasound is being used in conjunction with the photoacoustic imaging
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Primary and Secondary Outcome Measures * All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy. * Willingness to participate in the study and able to provide informed consent. Inclusion Criteria for Exploratory Outcome Measures * At least 18 years of age * Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy . * Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy. * Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.
Exclusion criteria
* Male * Younger than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the impact of co-registered PAI/US on the potential reduction of benign surgeries as measured by the area under receiver characteristic curve (AUC) | At the time of surgery (estimated to be 2 weeks) | The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection | At the time of surgery (estimated to be 2 weeks) | The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine if co-registered PAI/US can be used as a sensitive and specific screening tool for early detection of malignant neoangiogenesis within a group of high-risk women | Through completion of follow-up (estimated to be 4.5 years) | The investigators hope to improve current practice by detecting early cancers from this group of high-risk women |
| Determine normal changes of photoacoustic imaging parameters | Through completion of follow-up (estimated to be 4.5 years) | The investigators expect to see small changes of the PAI/US imaging parameters of less than 10-15 for repeated measurements of 3 menstrual cycles |
Countries
United States
Contacts
Primary ContactCary L Siegel, M.D.
Outcome results
None listed